FDA Approved: TADALAFIL — Original Application (Burel Pharmaceuticals, LLC)

View source ↗

Summary

The FDA approved a generic tadalafil product under an original ANDA for Burel Pharmaceuticals, LLC.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Benign Prostatic Hyperplasia
• Erectile Dysfunction
• Pulmonary Arterial Hypertension

Drugs mentioned

• TADALAFIL (TADALAFIL)

Snippet

ORIG AP for TADALAFIL (TADALAFIL)